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Completed

NCT Number: NCT03025711

Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine

The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Puerta de Hierro University Hospital

Madrid, 28222, Spain

About this study

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
  • Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion criteria

  • Given the characteristics of the study there are no exclusion criteria.

Treatment and study plan

Primary outcomes

  1. Overall survival.

    Time frame: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).

    The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive

Secondary outcomes

  1. Progression free survival.

    Time frame: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)

    The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).

  2. Best overall response rate

    Time frame: Through study completion, an average of 4 year

    Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record

  3. Duration of response (DOR)

    Time frame: Through study completion, an average of 4 year

    The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.

  4. Time to treatment failure

    Time frame: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)

  5. Time to Objective Response

    Time frame: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)

    The time from start of treatment to the date of the first confirmed response (evaluated for responders only)

  6. Time to change treatment

    Time frame: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)

  7. Time to next treatment

    Time frame: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)

  8. All suspected Grade 3/4/5 adverse reactions

    Time frame: Through study completion, an average of 4 year

  9. Adverse events of special interest to anti HER2 Mab (AESI)

    Time frame: Through study completion, an average of 4 year

    • AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
    • AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease

  10. AEs of scientific interest

    Time frame: Through study completion, an average of 4 year

    • An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
    • Other AEs leading to treatment discontinuation

Sponsors and collaborators

Lead sponsor

BELEN RUIZ-ANTORAN

Other

Registry information

Official study title

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

Acronym: KNOWHER

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jan 19, 2017
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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